FDA.reportPublic FDA data

Paxis 100 Auto

Primary DI
S10000110R0
Brand
Paxis 100 Auto
Company
Pausch, L.L.C.
Model
RH
Catalog number
S10000110L
Device description
Paxis 100 Auto Right Hand
Published
2023-05-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IYBTube Mount, X-Ray, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYBTube Mount, X-Ray, DiagnosticRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
S10000110R0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
X-ray system tube support, floor standingA component of an x-ray system (diagnostic, therapeutic, radiation therapy simulator) intended to be placed on the floor to mount, support and facilitate positioning of the x-ray tube assembly (not included). It typically consists of a rack with controls mounted on a base plate. The x-ray tube assembly is attached to the rack and can be moved along the rack and/or tilted. Some designs also support the movement and positioning of an image receptor assembly (e.g., C-arm assembly).

Regulatory Flags#

DUNS number
080365572
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
S062110000ElevatorMaxBaseS 0621 10002024-04-24
B884SVMS4000VMS 400BaseSVMS4002024-02-16
B884S10000110R0Paxis 100 AutoRHS10000110R2023-05-12
B884S10000110L0Paxis 100 AutoLHS10000110L2023-05-03
B884SMPRTHD0PATIENT TABLE RegularS MPRTHD2023-01-27
B884S06211100L0CombiMaxLeft HandS 0621 1100LH2022-12-28
B884S06211100R0CombiMaxRight HandS 0621 1100RH2022-12-28
B884SFS100L0FS 100 WallstandLeft HandS FS 100 LH2022-12-28
B884SFS100R0FS 100 WallstandRight HandS FS 100 RH2022-12-28
B884S04201000L0CirrusLS 0420 1000L2022-12-23
B884S04201000R0CirrusRS 0420 1000R2022-12-23
B884S100002000Paxis 200BaseS100002002022-12-23
B884SMPRT0PATIENT TABLERegularS MPRT2022-12-23
SMPRT0PATIENT TABLERegularS MPRT2022-12-07
B884S10000100L0Paxis 100LHS10000100L2022-12-06
B884S10000100R0Paxis 100RHS10000100R2022-12-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809832900302SST-4100SSHINYOUNG FOR M CO.,LTD.IYB2026-05-27
00198953054949NAGE Hualun Medical Systems Co., LtdIYB2025-09-30
00195278901880NAGE Hualun Medical Systems Co., LtdIYB2025-06-09
00860008892768Foot and Ankle StandOXOS Medical, Inc.IYB2025-06-02
08800011103088DRGEMDRGEM CorporationIYB2024-10-24
08800011103095DRGEMDRGEM CorporationIYB2024-10-24
08800011103125DRGEMDRGEM CorporationIYB2024-10-24
08800011103132DRGEMDRGEM CorporationIYB2024-10-24
08800011103163DRGEMDRGEM CorporationIYB2024-10-24
08800011103170DRGEMDRGEM CorporationIYB2024-10-24
08809832900258SD-3100SHINYOUNG FOR M CO.,LTD.IYB2024-04-04
B884SVMS4000VMS 400Pausch, L.L.C.IYB2024-02-16
08809832900074LSS-2000SHINYOUNG FOR M CO.,LTD.IYB2023-11-20
08809832900098SST-3100SHINYOUNG FOR M CO.,LTD.IYB2023-11-20
08809832900104SST-3001SHINYOUNG FOR M CO.,LTD.IYB2023-11-20
08809832900227SS-2100SHINYOUNG FOR M CO.,LTD.IYB2023-11-20
08809832900234SS-2100SHINYOUNG FOR M CO.,LTD.IYB2023-11-20
05999116100269F100 TS99N TUBE MOUNTCONTROL-X Medical Kereskedelmi és Szolgáltató Zártkörűen Működő RészvénytársaságIYB2023-08-15
D678A63410"Provecta HD 16"" Center to Center Wall Mounting Plate"AIR TECHNIQUES, INC.IYB2023-07-11
D678A63890Provecta HD Single Post Mounting PlateAIR TECHNIQUES, INC.IYB2023-07-11
D678A63301Provecta HD 16" Center to Center Wall Mounting PlateAIR TECHNIQUES, INC.IYB2023-07-11
D678A63361Provecta HD Single Post Mounting PlateAIR TECHNIQUES, INC.IYB2023-07-11
B884S10000110R0Paxis 100 AutoPausch, L.L.C.IYB2023-05-12
B884S10000110L0Paxis 100 AutoPausch, L.L.C.IYB2023-05-03
B884S04201000L0CirrusPausch, L.L.C.IYB2022-12-23
B884S04201000R0CirrusPausch, L.L.C.IYB2022-12-23
B884S100002000Paxis 200Pausch, L.L.C.IYB2022-12-23
B884S10000100L0Paxis 100Pausch, L.L.C.IYB2022-12-06
B884S10000100R0Paxis 100Pausch, L.L.C.IYB2022-12-06
00195278569745NAGE Hualun Medical Systems Co., LtdIYB2022-07-21